Class I - Dangerous
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
Class I - Dangerous
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, NDC 0904-6665-61
The Harvard Drug Group
Class I - Dangerous
Defective container; blister packaging inadequately sealed.
Class I - Dangerous
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30120 5
Church & Dwight
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Class I - Dangerous
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class I - Dangerous
Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
Class I - Dangerous
Failed Impurity/Degradation Specifications
Class I - Dangerous
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3632-98.
Orient Pharma Co., Ltd. Yunlin Plant
Class I - Dangerous
Failed Impurities/Degradation Specifications.
ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 30165 6
Church & Dwight
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Class I - Dangerous
Defective container; blister packaging inadequately sealed.
Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Thrive Health and Wellness, LLC
Class I - Dangerous
Lack of Assurance of Sterility
Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Thrive Health and Wellness, LLC
Class I - Dangerous
Lack of Assurance of Sterility
Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Thrive Health and Wellness, LLC
Class I - Dangerous
Lack of Assurance of Sterility
Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Croatia, Manufactured for Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 0093-2203-01.
Teva Pharmaceuticals USA
Class I - Dangerous
Presence of foreign tablets/capsules.
Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Thrive Health and Wellness, LLC
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10
Fresenius Medical Care Holdings
Class I - Dangerous
Lack of Assurance of Sterility